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Acute Radiation Syndrome (ARS)

Secretory Diarrhea

NSAID-InducedGastric Erosions

Technology Details

ACUTE RADIATION SYNDROME (ARS)

Rx100 for Acute Radiation Syndrome (ARS)

- including GI-ARS and HEM-ARS

Acute Radiation Syndrome results from external exposure to ionizing-radiation from sources such as: a) military use (Hiroshima, Nagasaki) & testing (Bikini Atoll), b) nuclear accidents (Chernobyl, etc.), c) manufacture & use of nuclear material & reactors (Los Alamos, Soviet Submarine K27), and d) terrorist attacks (i.e. deployment of “dirty bombs,” etc.). Acute death from ARS results from damage to radiosensitive organs such as bone marrow (hematological or Hem-ARS) or gastrointestinal stem cells (GI-ARS). Estimates are that casualties resulting from the detonation of an improvised nuclear device in a densely populated area would number in the hundreds of thousands. Currently, there are no FDA approved medical countermeasures against gastrointestinal radiation injury. There is an urgent unmet medical need for the development of medical countermeasures that are safe and effective.

Treatment of gastrointestinal (GI) Acute Radiation Syndrome (ARS) is currently the limiting step in survival from exposure to potentially lethal ionizing radiation from a nuclear explosion, nuclear power accident or terrorist-inspired improvised nuclear detonation. Death from GI-ARS occurs rapidly in the first 10 days or so. RxBio’s lead product, Rx100, is a small-molecule analog of an endogenous prosurvival molecule that has been metabolically stabilized conducive to once-daily dosing. Rx100 has been shown to be effective either before, during, or up to 72 hours after exposure to lethal radiation. Rx100 has shown significant efficacy for GI-ARS in multiple species and multiple animal models.

Rx100 has shown significant efficacy for GI-ARS in both large and small animal models with survival as the endpoint. To date, we have successfully completed quality manufacturing, pharmacology, and many of the IND-enabling toxicology predicates to human safety testing. Rx100 is in the development stages and has been largely funded through government grants and contracts due to the critical lack of available treatments in this area of national interest. The development pathway continues to be guided through timely interactions with FDA.

CHOLERA- AND TOXIN-INDUCED SECRETORY DIARRHEA

Rx100 for cholera toxin

Diarrheal disease is a severe health problem with an estimated 1.5 million deaths per year and is the second leading cause of death in children under the age of 5. A critical barrier in treating diarrheal disease is easy-to-use effective treatments. Existing treatments often depend on reconstituting medicines with contaminated water which is often the source of the problem. Our goal is to develop a safe, effective, and easy-to-use treatment for secretory diarrhea.

RxBio’s lead molecule, Rx100 is a metabolically stable analog of lysophosphatidic acid (LPA). Our preliminary data showed that Rx100 significantly inhibited toxin-induced and mediated secretory diarrhea. Rx100 could prove to be a very effective first line treatment strategy for prevention of diarrhea irrespective of the cause of diarrhea (enterotoxins, radiation, chemo, infection etc).

NSAID-INDUCED GASTRIC EROSIONS

Rx100 for prevention of NSAID-induced stomach erosions

RxBio has generated evidence that Rx100 and Rx300 series of compounds prevent gastric erosions and bleeding caused by nonsteroidal anti-inflammatory drugs (NSAID) such as aspirin and indomethacin. Rx compounds if taken in combination or after NSAID prevent erosions and bleeding in animal models of the human condition.